CMS Proposes Medicare Coverage For Artificial Hearts Manufactured By Abiomed, SynCardia

Main Category: Medical Devices / Diagnostics
Also Included In: Cardiovascular / Cardiology;  Medicare / Medicaid / SCHIP
Article Date: 06 Feb 2008 - 9:00 PDT

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Artificial heart manufacturers Abiomed and SynCardia Systems on Monday announced that CMS has proposed to extend Medicare coverage to the devices for beneficiaries who participate in clinical trials approved by FDA, the AP/Boston Herald reports. The proposal opens a 30-day public comment period, with CMS expected to issue a final Medicare coverage decision by May 1.

The proposal would reverse a policy established in 1986 that denied Medicare coverage for artificial hearts, which only the sickest patients receive. FDA officials on Friday said that "there is now sufficient scientific evidence on the use of artificial hearts to allow coverage" for Medicare beneficiaries enrolled in trials approved by the agency.

Three private health insurers recently announced they would cover AbioCor, an artificial heart manufactured by Abiomed. FDA in September 2006 allowed Abiomed to market AbioCor, which cost about $250,000, to about 4,000 of the sickest patients. No patients to date have received AbioCor. According to Abiomed officials, Medicare coverage for AbioCor might not lead to increased use of the device but might address some related cost concerns. Abiomed Chair, President and CEO Michael Minogue said, "We now have a validation from the FDA that this technology works, and we have some proposed validation" from CMS.

FDA in October 2004 approved the CardioWest temporary Total Artificial Heart, manufactured by SynCardia. More than 700 terminally ill heart failure patients to date have received CardioWest as they waited for transplants.

Gregory Simpson, an analyst with Stifel Nicolaus who tracks Abiomed, on Monday in a research note said that most investors would consider Medicare coverage for AbioCor a "nonevent" (AP/Boston Herald, 2/4).

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